BD EleVation Instructions For Use Manual page 6

NOTE: Ultrasound image guidance should be used to confirm BD EleVation™ Probe position relative
to the target region to be sampled.
NOTE: Do not leave the BD EleVation™ Breast Biopsy System unattended with the BD EleVation™
Probe in the primed state.
NOTE: During the initial positioning of the BD EleVation™ Probe, it is possible to advance the
inner needle and cutting cannula into the tissue using the available PRIME/PIERCE option. During
subsequent samplings, the physician may wish to forego this step.
NOTE: The BD EleVation™ Probe may be primed for piercing while inside the patient if the needle
needs to be advanced to dense tissues or lesions.
4. Acquire sample by pressing the SAMPLE button. The sampling process proceeds automatically
a. BD EleVation™ Driver creates a vacuum
b. Cutting cannula of the BD EleVation™ Probe retracts to expose the sample notch
c. Tissue is drawn to the sample notch by vacuum
d. Cutting cannula advances to cut the tissue
e. Tissue is transported to the sample container by vacuum
During this process, the SAMPLE button continually illuminates red and the PRIME/PIERCE button is
deactivated. After the tissue sample is deposited into the sample container, the BD EleVation™ Breast
Biopsy System resets to acquire another sample, and the SAMPLE and PRIME/PIERCE buttons will
illuminate green.
NOTE: Do not twist the sample container or remove the sample container while acquiring tissue
samples. If the BD EleVation™ Breast Biopsy System detects an error related to the sample container
inhibiting the vacuum seal, the device will not work. To return the sample container into the BD
EleVation™ Driver, clear any tissue underneath the sample container or from the BD EleVation™ Probe
where the sample container is seated, insert the sample container back into the BD EleVation™ Probe
and twist clockwise to ensure the sample container is properly in place.
NOTE: The BD EleVation™ Half-Notch Support Cannula may be used for thin breasts and/or
superficial lesions. If utilized, the optional BD EleVation™ Half-Notch Support Cannula (Figure 7)
should be removed from the package using aseptic technique and replace the support cannula
included with the BD EleVation™ Probe. The BD EleVation™ Half-Notch Support Cannula will reduce
the length of the sample notch from 2cm to 1cm.
5. To acquire multiple samples, repeat Step 4 above.
NOTE: Collecting multiple tissue samples may help minimize the risk of a false negative biopsy.
6. Turn the sample container counterclockwise to remove from the driver. Remove the tissue
samples from the sample container by hinging it open. If additional samples are required,
replace the sample container into the device by turning clockwise to lock into place. Ensure
the sample container is secure before acquiring additional samples.
To replace sample container
NOTE: Removal of the sample container during the sample sequence will result in loss of vacuum.
Dead Space
NOTE: Prior to removing the BD EleVation™ Probe from the breast, the support cannula may be
detached and remain in the breast to retain a track to the biopsy site to place a tissue marker.
NOTE: To remove the support cannula from the BD EleVation™ Probe, depress the coaxial arm and
twist the coaxial hub.
7. After obtaining the final tissue sample, remove the BD EleVation™ Probe from the breast and
care for the incision site as appropriate.
NOTE: If experiencing difficulty removing the BD EleVation™ Probe from the breast, first detach
integrated support cannula. Then, holding the support cannula in place, remove BD EleVation™
Probe from breast.
NOTE: The sample container may be removed before or after the BD EleVation™ Probe is removed
from the BD EleVation™ Driver.
8. Remove the BD EleVation™ Probe from the BD EleVation™ Driver by pressing down on the
locking tab, sliding the BD EleVation™ Probe cover completely forward and then pulling the
BD EleVation™ Probe straight up from the BD EleVation™ Driver (Figure 13).
9. The BD EleVation™ Probe, support cannula, sample container, and any BD EleVation™
Accessory used in this procedure is for single-use only. After use, these products may be a
potential biohazard. Handle and dispose of in accordance with accepted medical practice and
local, state, and federal laws and regulations. Dispose of sharps in designated sharps disposal
containers; these are single-use devices and therefore should be disposed appropriately, not
recapped or resterilized.
Figure 8
Closed
Sample Container
1cm
To remove sample container
Open
Figure 10
Figure 11
Figure 12
Figure 13
6
Figure 9